# K222706: iCE-SG2 Subcutaneous Electrode Kit

- Pathway: 510(k) (Traditional)
- Applicant: Ice Neurosystems, Inc.
- Decided: Dec 6, 2022 after 90 days
- Product code: GZL (Electrode, Depth)
- Device class: 2
- Regulation: 21 CFR 882.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K811452 (1981). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201678: iCE-SG Subcutaneous Electrode Arrays, Ice Neurosystems, Inc. (2021) Summary page 4.

## Indications for use
iCE-SG2 Subcutaneous Electrode Kit is intended for temporary (<14 days) use with recording and monitoring equipment for the recording and monitoring of electrical signals at the subsurface level of the brain.

Source page: https://510kreport.com/device/K222706
Methodology: https://510kreport.com/methodology